ECSP088485A - SOLUTION OF SODIUM CHLORIDE FOR RECONSTITUTION OR DILUTION OF FARMACO - Google Patents
SOLUTION OF SODIUM CHLORIDE FOR RECONSTITUTION OR DILUTION OF FARMACOInfo
- Publication number
- ECSP088485A ECSP088485A EC2008008485A ECSP088485A ECSP088485A EC SP088485 A ECSP088485 A EC SP088485A EC 2008008485 A EC2008008485 A EC 2008008485A EC SP088485 A ECSP088485 A EC SP088485A EC SP088485 A ECSP088485 A EC SP088485A
- Authority
- EC
- Ecuador
- Prior art keywords
- injection
- prevent
- reconstitution
- dilution
- sodium chloride
- Prior art date
Links
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 title abstract 4
- 239000000243 solution Substances 0.000 title abstract 4
- 239000012895 dilution Substances 0.000 title abstract 2
- 238000010790 dilution Methods 0.000 title abstract 2
- 239000011780 sodium chloride Substances 0.000 title abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 abstract 6
- 238000002347 injection Methods 0.000 abstract 5
- 239000007924 injection Substances 0.000 abstract 5
- 206010018910 Haemolysis Diseases 0.000 abstract 3
- 230000004520 agglutination Effects 0.000 abstract 3
- 210000004027 cell Anatomy 0.000 abstract 3
- 230000008602 contraction Effects 0.000 abstract 3
- 230000008588 hemolysis Effects 0.000 abstract 3
- 238000000034 method Methods 0.000 abstract 3
- 230000018044 dehydration Effects 0.000 abstract 1
- 238000006297 dehydration reaction Methods 0.000 abstract 1
- 210000003743 erythrocyte Anatomy 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
La invención proporciona métodos para la preparación de formulaciones farmacéuticas para inyección tal que en la inyección la formulación no provoque la aglutinación de eritrocitos, hemólisis, y/o contracción de células. Para prevenir la aglutinación, una formulación farmacéutica preparada para inyección necesita tener una fuerza iónica suficiente. Para prevenir la hemólisis o la contracción de células, una formulación farmacéutica preparada para inyección necesita ser casi isotónica con respecto al plasma. La invención proporciona métodos que preparan formulaciones farmacéuticas para inyección que tienen tanto la fuerza iónica suficiente para prevenir la aglutinación y la tonicidad requerida para prevenir hemólisis o deshidratación o contracción de células significativas. Los métodos presentes involucran el uso de soluciones de cloruro de sodio que son alrededor de 25 MM hasta alrededor de 150 mM para reconstitución de tortas liofilizadas (u otras formulaciones farmacéuticas no líquidas) en solución o para dilución de soluciones de formulación farmacéutica.The invention provides methods for the preparation of pharmaceutical formulations for injection such that in the injection the formulation does not cause erythrocyte agglutination, hemolysis, and / or cell contraction. To prevent agglutination, a pharmaceutical formulation prepared for injection needs to have sufficient ionic strength. To prevent hemolysis or cell contraction, a pharmaceutical formulation prepared for injection needs to be almost isotonic with respect to plasma. The invention provides methods that prepare pharmaceutical formulations for injection that have both sufficient ionic strength to prevent agglutination and tonicity required to prevent hemolysis or dehydration or contraction of significant cells. The present methods involve the use of sodium chloride solutions that are about 25 MM to about 150 mM for reconstitution of lyophilized cakes (or other non-liquid pharmaceutical formulations) in solution or for dilution of pharmaceutical formulation solutions.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US73222105P | 2005-11-01 | 2005-11-01 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ECSP088485A true ECSP088485A (en) | 2008-06-30 |
Family
ID=37801586
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EC2008008485A ECSP088485A (en) | 2005-11-01 | 2008-05-30 | SOLUTION OF SODIUM CHLORIDE FOR RECONSTITUTION OR DILUTION OF FARMACO |
Country Status (31)
| Country | Link |
|---|---|
| US (4) | US20070135343A1 (en) |
| EP (3) | EP3593790A1 (en) |
| JP (1) | JP5555425B2 (en) |
| KR (2) | KR20110128957A (en) |
| CN (1) | CN101351190B (en) |
| AR (2) | AR056748A1 (en) |
| AU (1) | AU2006308921C1 (en) |
| BR (1) | BRPI0618133A2 (en) |
| CA (1) | CA2626531C (en) |
| CR (1) | CR9958A (en) |
| DK (2) | DK3225233T3 (en) |
| EC (1) | ECSP088485A (en) |
| ES (2) | ES2749574T3 (en) |
| FI (1) | FI1942868T4 (en) |
| FR (1) | FR20C1005I1 (en) |
| GT (1) | GT200800037A (en) |
| HK (1) | HK1245090B (en) |
| HU (4) | HUE045421T2 (en) |
| IL (1) | IL190843A (en) |
| LU (1) | LUC00035I2 (en) |
| MY (1) | MY184364A (en) |
| NO (1) | NO347263B1 (en) |
| NZ (1) | NZ567685A (en) |
| PE (3) | PE20151284A1 (en) |
| PL (2) | PL1942868T5 (en) |
| PT (2) | PT3225233T (en) |
| RU (1) | RU2432157C2 (en) |
| SI (2) | SI1942868T2 (en) |
| TW (1) | TWI480063B (en) |
| UA (1) | UA97234C2 (en) |
| WO (1) | WO2007053533A2 (en) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL1942868T5 (en) | 2005-11-01 | 2023-12-27 | Wyeth Llc | Sodium chloride solution for drug reconstitution or dilution |
| US7767206B2 (en) | 2006-10-02 | 2010-08-03 | Amgen Inc. | Neutralizing determinants of IL-17 Receptor A and antibodies that bind thereto |
| US8431011B2 (en) * | 2008-01-31 | 2013-04-30 | Abbott Diabetes Care Inc. | Method for automatically and rapidly distinguishing between control and sample solutions in a biosensor strip |
| EP2501367B1 (en) * | 2009-11-17 | 2015-01-21 | Ipsen Pharma S.A.S. | Formulation for HGH and RHIGF-1 combination |
| US10634741B2 (en) | 2009-12-04 | 2020-04-28 | Endomagnetics Ltd. | Magnetic probe apparatus |
| US9427186B2 (en) | 2009-12-04 | 2016-08-30 | Endomagnetics Ltd. | Magnetic probe apparatus |
| PH12012501364A1 (en) | 2010-01-15 | 2012-10-22 | Amgen K A Inc | Antibody formulation and therapeutic regimens |
| NZ602685A (en) | 2010-03-01 | 2014-10-31 | Cytodyn Inc | Concentrated protein formulations and uses thereof |
| PL3552619T3 (en) | 2010-07-09 | 2025-12-01 | Bioverativ Therapeutics Inc. | Factor ix polypeptides and methods of use thereof |
| HK1213521A1 (en) * | 2012-09-25 | 2016-07-08 | Bioverativ Therapeutics Inc. | Methods of using fix polypeptides |
| ES2803506T3 (en) | 2013-03-11 | 2021-01-27 | Endomagnetics Ltd | Hypoosmotic solutions for lymph node detection |
| US9234877B2 (en) | 2013-03-13 | 2016-01-12 | Endomagnetics Ltd. | Magnetic detector |
| US9239314B2 (en) | 2013-03-13 | 2016-01-19 | Endomagnetics Ltd. | Magnetic detector |
| WO2014144549A1 (en) * | 2013-03-15 | 2014-09-18 | Biogen Idec Ma Inc. | Factor ix polypeptide formulations |
| FR3005420B1 (en) | 2013-05-07 | 2015-09-18 | Erytech Pharma | METHOD OF STABILIZING SUSPENSIONS OF ERYTHROCYTES ENCAPSULATING AN ACTIVE INGREDIENT, SUSPENSIONS OBTAINED |
| AU2015236340B2 (en) * | 2014-03-24 | 2020-02-06 | Bioverativ Therapeutics Inc. | Lyophilized factor IX formulations |
| US9351945B1 (en) | 2015-02-27 | 2016-05-31 | John Daniel Dobak, III | Reduction of adipose tissue |
| GB2536703B (en) * | 2015-03-27 | 2020-12-02 | Ge Healthcare Bio Sciences Ab | Method for baseline correction in a chromatogram |
| EP3081942A1 (en) * | 2015-04-17 | 2016-10-19 | Roche Diagniostics GmbH | Pressure transmission liquid for cellular analyzer, cellular analyzer and method for analyzing a liquid cellular sample |
| MX390935B (en) | 2015-06-04 | 2025-03-21 | Endomagnetics Ltd | MARKER MATERIALS AND FORMS FOR LOCATION OF MAGNETIC MARKERS (MML). |
| US10124021B2 (en) * | 2016-12-23 | 2018-11-13 | Andrew L. Gostine | Intravenous fluid |
| JP7110360B2 (en) | 2017-10-09 | 2022-08-01 | テルモ ビーシーティー バイオテクノロジーズ，エルエルシー | Freeze-drying method |
| CN113597532B (en) | 2019-03-14 | 2023-02-17 | 泰尔茂比司特生物技术有限公司 | Freeze-dried container filling fixture, system and method of use |
| US12036187B2 (en) * | 2019-05-01 | 2024-07-16 | Southwest Research Institute | Compositions of dimethyl trisulfide (DMTS) as a cyanide antidote |
| WO2021108051A2 (en) * | 2019-10-25 | 2021-06-03 | Cmc Pharmaceuticals, Inc. | Atropine-scopolamine with enhanced stability |
| IL272145A (en) * | 2020-01-20 | 2021-07-29 | Stem Cell Medicine Ltd | Cosmetic preparations with protein concentrate from a conditioned growth medium of stem cells from adipose tissue |
| JP2023538831A (en) * | 2020-08-03 | 2023-09-12 | トランスルミナル、システムズ、リミテッド、ライアビリティー、カンパニー | Device and method for transarterial osmotic embolization of pathological tissue |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3717708A (en) * | 1968-10-24 | 1973-02-20 | Cutter Lab | Blood coagulation complex |
| US4364861A (en) | 1980-05-27 | 1982-12-21 | Cutter Laboratories, Inc. | Blood-coagulation-promoting products and methods of preparing them |
| US6372716B1 (en) | 1994-04-26 | 2002-04-16 | Genetics Institute, Inc. | Formulations for factor IX |
| DK1820516T3 (en) | 1999-02-22 | 2013-10-28 | Univ Connecticut | New albumin-free factor VIII preparations |
| US20010031721A1 (en) * | 1999-05-05 | 2001-10-18 | Chandra Webb | Highly concentrated, lyophilized, and liquid factor IX formulations |
| AU2002213441B2 (en) * | 2000-10-12 | 2006-10-26 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
| CN1917861B (en) | 2003-12-19 | 2012-03-21 | 诺和诺德医疗保健公司 | Stabilised compositions of factor vii polypeptides |
| BRPI0509117A (en) | 2004-03-04 | 2007-08-28 | Wyeth Corp | lyophilization method to improve crystallization of excipients |
| PL1942868T5 (en) | 2005-11-01 | 2023-12-27 | Wyeth Llc | Sodium chloride solution for drug reconstitution or dilution |
-
2006
- 2006-10-27 PL PL06827036.2T patent/PL1942868T5/en unknown
- 2006-10-27 CA CA2626531A patent/CA2626531C/en active Active
- 2006-10-27 DK DK17166616.7T patent/DK3225233T3/en active
- 2006-10-27 HU HUE17166616A patent/HUE045421T2/en unknown
- 2006-10-27 PE PE2015001729A patent/PE20151284A1/en not_active Application Discontinuation
- 2006-10-27 ES ES17166616T patent/ES2749574T3/en active Active
- 2006-10-27 NO NO20082180A patent/NO347263B1/en unknown
- 2006-10-27 PE PE2011000653A patent/PE20110803A1/en not_active Application Discontinuation
- 2006-10-27 EP EP19189599.4A patent/EP3593790A1/en not_active Withdrawn
- 2006-10-27 US US11/589,002 patent/US20070135343A1/en not_active Abandoned
- 2006-10-27 HU HUE06827036A patent/HUE033949T2/en unknown
- 2006-10-27 PL PL17166616T patent/PL3225233T3/en unknown
- 2006-10-27 RU RU2008119514/15A patent/RU2432157C2/en active
- 2006-10-27 TW TW095139724A patent/TWI480063B/en active
- 2006-10-27 KR KR1020117027131A patent/KR20110128957A/en not_active Withdrawn
- 2006-10-27 WO PCT/US2006/042258 patent/WO2007053533A2/en not_active Ceased
- 2006-10-27 EP EP06827036.2A patent/EP1942868B2/en active Active
- 2006-10-27 PT PT171666167T patent/PT3225233T/en unknown
- 2006-10-27 AU AU2006308921A patent/AU2006308921C1/en active Active
- 2006-10-27 DK DK06827036.2T patent/DK1942868T5/en active
- 2006-10-27 CN CN2006800400807A patent/CN101351190B/en active Active
- 2006-10-27 PT PT68270362T patent/PT1942868T/en unknown
- 2006-10-27 EP EP17166616.7A patent/EP3225233B1/en not_active Revoked
- 2006-10-27 SI SI200632172T patent/SI1942868T2/en unknown
- 2006-10-27 KR KR1020087013252A patent/KR101126670B1/en active Active
- 2006-10-27 ES ES06827036T patent/ES2627684T5/en active Active
- 2006-10-27 NZ NZ567685A patent/NZ567685A/en unknown
- 2006-10-27 PE PE2006001318A patent/PE20070714A1/en not_active Application Discontinuation
- 2006-10-27 MY MYPI20081347A patent/MY184364A/en unknown
- 2006-10-27 UA UAA200807432A patent/UA97234C2/en unknown
- 2006-10-27 BR BRPI0618133-3A patent/BRPI0618133A2/en not_active Application Discontinuation
- 2006-10-27 JP JP2008538945A patent/JP5555425B2/en active Active
- 2006-10-27 SI SI200632348T patent/SI3225233T1/en unknown
- 2006-10-31 AR ARP060104769A patent/AR056748A1/en not_active Application Discontinuation
-
2008
- 2008-04-14 IL IL190843A patent/IL190843A/en active IP Right Grant
- 2008-04-17 GT GT200800037A patent/GT200800037A/en unknown
- 2008-05-07 CR CR9958A patent/CR9958A/en not_active Application Discontinuation
- 2008-05-30 EC EC2008008485A patent/ECSP088485A/en unknown
-
2016
- 2016-10-07 US US15/288,860 patent/US20170021022A1/en not_active Abandoned
-
2017
- 2017-09-25 LU LU00035C patent/LUC00035I2/fr unknown
- 2017-09-27 HU HUS1700035C patent/HUS1700035I1/en unknown
-
2018
- 2018-04-04 HK HK18104477.4A patent/HK1245090B/en unknown
- 2018-07-06 AR ARP180101902 patent/AR112443A2/en not_active Application Discontinuation
-
2019
- 2019-12-20 US US16/723,563 patent/US20200138952A1/en not_active Abandoned
-
2020
- 2020-01-31 HU HUS2000003C patent/HUS2000003I1/en unknown
- 2020-02-10 FR FR20C1005C patent/FR20C1005I1/en active Active
- 2020-07-14 US US16/946,998 patent/US20200338199A1/en not_active Abandoned
-
2023
- 2023-03-17 FI FIEP06827036.2T patent/FI1942868T4/en active
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